UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049896 |
|---|---|
| Receipt number | R000056830 |
| Scientific Title | Research on causative organisms of sexually transmitted infections |
| Date of disclosure of the study information | 2022/12/26 |
| Last modified on | 2023/12/27 17:14:29 |
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Basic information
Public title
Research on causative organisms of sexually transmitted infections
Acronym
Research on causative organisms of sexually transmitted infections
Scientific Title
Research on causative organisms of sexually transmitted infections
Scientific Title:Acronym
Research on causative organisms of sexually transmitted infections
Region
| Japan |
Condition
Condition
sexually transmitted infections
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this project is to collect Neisseria gonorrhoeae and Mycoplasma genitalium, which are the causative bacteria of sexually transmitted infections and antimicrobial resistance is a worldwide problem, on a nationwide scale, and to investigate antimicrobial susceptibility and molecular types of N. gonorrhoeae and M genitalium as a antimicrobial susceptibility surveillance in Japan comparable to surveillance in other countries.
Basic objectives2
Others
Basic objectives -Others
The objective is to clarify the drug resistance mechanism.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is the minimum inhibitory concentration of antimicrobial agents against each bacterium as an antimicrobial susceptibility test.
Key secondary outcomes
The secondary endpoints are the drug resistance mechanism and analysis by molecular type.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who have given consent for this study
(ii) Patients for whom information on medical treatment and prognosis can be obtained from their medical records.
Key exclusion criteria
Patients who have requested not to participate in this study
Target sample size
7500
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Yasuda |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Infection Control & Laboratory Medicine
Zip code
060-8543
Address
S1 W16,Chuo-ku,Sapporo
TEL
011-611-2111
yasuda7jpe@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Yasuda |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Infection Control & Laboratory Medicine
Zip code
060-8543
Address
S1 W16,Chuo-ku,Sapporo
TEL
011-611-2111
Homepage URL
yasuda7jpe@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University School of Medicine
Address
S1 W16,Chuo-ku,Sapporo
Tel
011-611-2111
ji-rskk@sapmed.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Specimens (urethral secretions, urine, throat wipes, gargle fluid, cervical mucus, etc.) obtained from patients with sexually transmitted diseases at the collaborating institutions will be sent to our hospital for isolation and culture. DNA of the pathogenic microorganisms will be extracted. For gonorrhea, chlamydia, MG, etc. that can be cultured, antimicrobial susceptibility testing is conducted in accordance with the standard methods of the Japanese Society of Chemotherapy and the Clinical Laboratory Standard Institute (CLSI). For Neisseria gonorrhoeae, Chlamydia, and MG that are found to be drug-resistant by drug susceptibility testing, the mechanism of drug resistance will be examined. These results will be used for reporting to the AMED research group (antimicrobial susceptibility, molecular typing, and drug resistance mechanisms), the MHLW research group (antimicrobial susceptibility, molecular typing, and drug resistance mechanisms), the Joint Antimicrobial Susceptibility Surveillance of Three Societies (antimicrobial susceptibility, molecular typing), and WHO GLASS (resistance rates).
Management information
Registered date
| 2022 | Year | 12 | Month | 26 | Day |
Last modified on
| 2023 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056830
